Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- MEAN ARTERIAL PRESSURE (MAP)
Study Overview
Brief Summary
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)
Detailed Description
In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.
All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.
The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated
Exclusion Criteria
- •Glasgow score >8
- •Bilateral mydriasis at the initial management
Arms & Interventions
EV1000 monitor
MAP management will be done as usual ( adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system
Intervention: EV1000 and closed-loop system (Device)
EV1000 monitor + closed-loop system
fluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration
Intervention: EV1000 and closed-loop system (Device)
Outcomes
Primary Outcomes
MEAN ARTERIAL PRESSURE (MAP)
Time Frame: 48 hours post-admission in the intensive care
time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.
Secondary Outcomes
- Hypotension incidence(48 hours post-admission in the intensive care)
- Hypertension incidence(48 hours post-admission in the intensive care)
- Pulsatility index(48 hours post-admission to the intensive care unit)
- Mean velocity(48 hours post-admission to the intensive care unit)
- diastolic velocity(baseline (admission to the intensive care unit))
- Diastolic velocity(48 hours post-admission to the intensive care unit)
- Fluid received(48 hours post-admission in the intensive care)
- Amount of vasopressor(48 hours post-admission in the intensive care)
- Length of stay in the Intensive care unit(30 days post-admission in the intensive care)
- Mean arterial pressure (MAP)(48 hours post-admission in the intensive care)
- Stroke volume(48 hours post-admission in the intensive care)
- cardiac index(48 hours post-admission in the intensive care)
Investigators
Alexandre Joosten
Principal Investigator
Erasme University Hospital